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OpenTrials
Completed

NCT Number: NCT06053463

Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.

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Key information

Age range

38 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Optometry, Columbus, Ohio, United States

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About this study

The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to give informed consent.
  • Any gender.
  • Any racial or ethnic origin.
  • At least 38 years of age or older.
  • Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
  • Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
  • Spectacle sphere power range between +6.00 to -10.00.
  • Previously dropped out of contact lens wear due to vision or vision and discomfort.
  • Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI

Exclusion criteria

  • Current or active ocular inflammation or infection as determined by the Investigator.
  • Astigmatism ≥ 1.00 D in either eye.
  • History of previous eye surgery.
  • Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
  • Demonstration or history of corneal ectasia or keratoconus.
  • Pregnant or lactating

Treatment and study plan

Daily disposable multifocal soft contact lens

Device

Daily disposable multifocal soft contact lens that will be worn for 1 month.

Primary outcomes

  1. Visual Analog Scale

    Time frame: 1 month

    Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (> 50).

  2. Quality of Life Survey

    Time frame: 1 month

    Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.

Sponsors and collaborators

Lead sponsor

Jennifer Fogt

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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